USA News Group CommentaryIssued on behalf of Oncolytics Biotech Inc.

美国新闻集团评论代表Oncolytics Biotech Inc.发布。

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a 'highly troubling' new study, the rising number of cancer cases in young people is being attributed to 'accelerated aging.' Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050.

不列颠哥伦比亚省温哥华2024年5月3日消息——根据一项“非常令人不安”的新研究，年轻人癌症病例的增加被归因于“加速衰老”联合国正在传播进一步的警报，其卫生当局预测，到2050年，全球癌症病例将增加约77%，预计富裕国家的癌症绝对增长率最高，预计2050年将新增480万例。

With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc.

Custom market Insights的分析师预测，到2032年，全球癌症免疫治疗市场将达到3144亿美元，复合年增长率将达到7.2%，生物技术部门在癌症治疗和诊断方面继续取得重大进展，最近的最新消息来自Oncolytics biotech Inc。

(NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN)..

（纳斯达克：ONCY）（TSX：ONC）、Celcuity Inc.（纳斯达克：CELC）、Olema Pharmaceuticals，Inc.（纳斯达克：OLMA）、Bio-Rad Laboratories，Inc.（纽约证券交易所：Bio）和AstraZeneca PLC（纳斯达克：AZN）。。

Since receiving Fast Track Designation from the FDA in late 2022 for its leading cancer treatment, pelareorep, in the treatment of pancreatic cancer, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has maintained strong progress. The company recently announced that it has requested a Type C meeting with the FDA to discuss an upcoming registration-enabling trial of pelareorep for treating HR+/HER2- metastatic breast cancer (mBC) patients..

自2022年末因其领先的癌症治疗pelareorep在胰腺癌治疗方面获得FDA快速通道指定以来，Oncolytics Biotech Inc.（纳斯达克股票代码：ONCY）（TSX股票代码：ONC）一直保持着强劲的进展。该公司最近宣布，它已要求与FDA举行C型会议，讨论即将进行的pelareorep治疗HR+/HER2转移性乳腺癌（mBC）患者的注册试验。。

'A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment,' said Matt Coffey, President and CEO of Oncolytics. 'We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.

溶瘤药物总裁兼首席执行官马特·科菲（MattCoffey）说，2024年溶瘤药物的一个关键重点是确定pelareorep在乳腺癌治疗中的监管路径我们乐观地认为，pelareorep联合紫杉醇可以显着提高HR+/HER2转移性乳腺癌患者的临床疗效。

Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration.'.

通过鼓励来自两项随机研究（手镯-1和IND-213）和AWARE-1研究的数据，我们的立场得到了加强，为pelareorep的下一阶段开发和注册铺平了道路。”。

Dr. Coffey has noted that ongoing collaborations with clinical collaborators have been key to preparing a comprehensive and convincing briefing document. Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.

科菲博士指出，与临床合作者的持续合作是编写全面而令人信服的简报文件的关键。Oncolytics Biotech要求在2024年第二季度与FDA会面，以最终确定使用pelareorep治疗转移性乳腺癌的注册试验设计和目标。

This meeting is essential for moving this promising treatment closer to patient use. With forthcoming survival data from its BRACELET-1 study and productive discussions with the FDA, Oncolytics is hopeful that 2024 will mark a significant milestone for the company and its stakeholders..

这次会议对于使这种有希望的治疗更接近患者使用至关重要。随着即将从其手镯-1研究中获得的生存数据以及与FDA的富有成效的讨论，Oncolytics希望2024年将成为该公司及其利益相关者的一个重要里程碑。。

'The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control,' said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics.

Oncolytics首席医学官Thomas Heineman医学博士说：“来自随机BREACK-1试验的数据显示，在HR+/HER2转移性乳腺癌患者中，pelareorep/紫杉醇联合治疗取得了令人信服的结果，确诊有效率几乎翻了三倍，中位无进展生存期提高了50%，与单独使用紫杉醇的对照组相比，风险比为0.29。”。

'Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients.'.

“重要的是，这些数据支持另一项随机2期研究IND-213的中位总生存率在统计学上显着接近翻倍，该研究还评估了HR+/HER2转移性乳腺癌患者的pelareorep和紫杉醇。”。

Another company that's developing targeted therapies for multiple cancer indications is Celcuity Inc. (NASDAQ: CELC). Within its latest Q4/FY 2023 financial results and corporate update, Celcuity spoke of how it had dosed its first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration-resistant prostate cancer..

另一家针对多种癌症适应症开发靶向治疗的公司是Celcuity Inc.（纳斯达克：CELC）。Celcuity在其最新的2023年第四季度财务结果和公司更新中谈到了它是如何在一项1b/2期试验中给第一名患者服用吉达托利西联合达洛他胺治疗转移性去势抵抗性前列腺癌的。。

'We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer,' said Igor Gorbatchevsky, M.D., Chief Medical Officer of Celcuity. 'A significant unmet need remains for patients with metastatic castration-resistant prostate cancer who have become resistant to a next generation androgen receptor inhibitor.'.

Celcuity首席医疗官Igor Gorbatchevsky医学博士说：“我们很高兴开始招募201试验的患者，并朝着为前列腺癌患者提供变革性治疗选择的最终目标迈进。”转移性去势抵抗性前列腺癌患者对下一代雄激素受体抑制剂产生耐药性的需求仍然没有得到满足。

Late last year, Celcuity also presented preclinical data on the therapeutic effects of gedatolisib in breast cancer models at the 2023 San Antonio Breast Cancer Symposium. As its flagship asset, Celcuity's gedatolisib is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR..

去年晚些时候，Celcuity还在2023年圣安东尼奥乳腺癌研讨会上介绍了吉达托利西在乳腺癌模型中治疗效果的临床前数据。作为其旗舰资产，Celcuity的gedatolisib是一种有效的可逆双重抑制剂，可选择性靶向所有I类PI3K亚型和mTOR。。

In the process of becoming an impressive comeback story, Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has moved from making job cuts in 2023 to moving forward with pivotal drug studies in 2024. Recently in March, Olema announced the publication of data highlighting its proprietary treatment palazestrant's (OP-1250) ability to inhibit wild-type and mutant ER+ breast cancer both as monotherapy and in combination with CDK4/6 inhibitors through a paper titled 'Palazestrant (OP-1250), a Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination.'.

在成为令人印象深刻的复出故事的过程中，Olema Pharmaceuticals，Inc.（纳斯达克：OLMA）已从2023年的裁员转变为2024年的关键药物研究。最近在3月，Olema宣布发布数据，突出其专有治疗palazestrant（OP-1250）抑制野生型和突变型ER+乳腺癌的能力，既可以作为单一疗法，也可以与CDK4/6抑制剂联合使用，通过一篇题为“palazestrant（OP-1250），一种完整的雌激素受体拮抗剂，抑制野生型和突变型ER阳性乳腺癌模型作为单一疗法和联合疗法。”。

'The research described in this paper reviews the deliberate design and processes used in discovering and optimizing palazestrant as a molecule purpose-built to address a crucial unmet need in the treatment of women's cancers, and we are delighted that Molecular Cancer Therapeutics has featured our work,' said David C.

David C.说：“本文描述的研究回顾了发现和优化palazestrant的精心设计和过程，palazestrant是一种专门用于解决女性癌症治疗中关键的未满足需求的分子，我们很高兴分子癌症治疗学成为我们工作的特色。”。

Myles, Ph.D., Olema's Chief Discovery and Non-Clinical Development Officer. 'What's even more exciting is to see how faithfully the pre-clinical research predicted the behavior of palazestrant now that it is in late-stage clinical development. We saw the potential then, as told in the paper, and we believe that every day brings us closer to having a real impact transforming the treatment paradigm for women with cancer.'.

奥莱玛的首席发现和非临床开发官迈尔斯博士说更令人兴奋的是，看到临床前研究多么忠实地预测了palazestrant现在处于临床开发后期的行为。正如论文所述，我们当时看到了潜力，我们相信每天都会让我们更接近真正的影响，改变癌症女性的治疗模式。”。

Helping to potentially detect breast cancer more easily, Bio-Rad Laboratories, Inc. (NYSE: BIO) recently launched its first ultrasensitive multiplexed digital PCR assay for breast cancer mutation detection in clinical research. The newly launched ddPLEX ESR1 Mutation Detection Kit assay expands Bio-Rad's Droplet Digital PCR (ddPCR™) offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring..

为了更容易地检测乳腺癌，Bio-Rad Laboratories，Inc.（纽约证券交易所：Bio）最近推出了其第一个超灵敏多重数字PCR检测方法，用于临床研究中的乳腺癌突变检测。新推出的ddPLEX ESR1突变检测试剂盒分析扩展了Bio-Rad的液滴数字PCR（ddPCR™）在肿瘤学市场的应用，在肿瘤学市场上，高灵敏度和多重突变检测分析有助于转化研究，治疗选择和疾病监测。。

'With the ddPLEX ESR1 Mutation Detection Kit, our customers can achieve new levels of sensitivity and multiplexing without compromising throughput,' said Stephen Kulisch, Vice President of Marketing for Bio-Rad's Digital Biology Group. 'This launch reflects our ongoing menu expansion in oncology and our commitment to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials that support improvements in patient monitoring.'.

Bio-Rad数字生物学集团营销副总裁斯蒂芬·库利什（StephenKulisch）说：“使用ddPLEX ESR1突变检测试剂盒，我们的客户可以在不影响吞吐量的情况下实现更高水平的灵敏度和多路复用。”此次发布反映了我们正在进行的肿瘤学菜单扩展，以及我们为肿瘤学研究人员提供技术的承诺，这些技术可以实现从生物标志物发现到支持改进患者监测的临床试验的一切。”。

Shortly after the launch, Bio-Rad partnered with Alleghany Health Network (AHN) to advance clinical evidence for monitoring solid tumor cancers using the ddPCR technology. The collaboration will use ddPCR technology for molecular residual disease (MRD) monitoring of patients across a range of solid tumor types..

启动后不久，Bio-Rad与Alleghany Health Network（AHN）合作，以推进使用ddPCR技术监测实体瘤癌症的临床证据。该合作将使用ddPCR技术对一系列实体瘤类型的患者进行分子残留病（MRD）监测。。

Even more promising breast cancer data has come out recently from AstraZeneca PLC (NASDAQ: AZN) and partners Daiichi Sankyo for their jointly developed antibody drug conjugate Enhertu (trastuzumab deruxtecan), from their phase 3 breast cancer trial. Results from the DESTINY-Breast06 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy..

最近，阿斯利康公司（NASDAQ:AZN）和合作伙伴第一三共（Daiichi Sankyo）从他们的3期乳腺癌试验中联合开发了抗体-药物偶联物Enhertu（曲妥珠单抗-德鲁替康），获得了更有希望的乳腺癌数据。DESTINY-Breast06试验的结果显示，与HR阳性，HER2低转移性乳腺癌患者的初级试验人群中的标准治疗化疗相比，无进展生存期（PFS）有统计学意义和临床意义的改善内分泌治疗。。

'DESTINY-Breast06 shows that ENHERTU could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy,' said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. 'These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer.'.

阿斯利康肿瘤研发执行副总裁苏珊·加尔布雷斯（SusanGalbraith）说：“DESTINY-Breast06表明，ENHERTU可能成为一种新的治疗标准，用于治疗一种或多种内分泌治疗后的HER2低和HER2超低转移性乳腺癌患者。”这些数据强调了在HR阳性乳腺癌范围内使用ENHERTU治疗的潜力，进一步重新定义了转移性乳腺癌的治疗方法。”。

Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/

文章来源：https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/

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美国新闻集团是Market IQ Media Group，Inc.（“MIQ”）的全资子公司。MIQ直接从该公司获得了Oncolytics Biotech Inc.广告和数字媒体的费用。可能有第三方持有Oncolytics Biotech Inc.的股份，并可能清算其股份，这可能会对股票价格产生负面影响。

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来源美国新闻集团